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Miltefosine
Impavido (miltefosine) is a small molecule pharmaceutical. Miltefosine was first approved as Impavido on 2014-03-19. It is used to treat cutaneous leishmaniasis, leishmaniasis, and visceral leishmaniasis in the USA. It is known to target RAC-alpha serine/threonine-protein kinase.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Impavido
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Miltefosine
Tradename
Company
Number
Date
Products
IMPAVIDOKnight TherapeuticsN-204684 RX2014-03-19
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
impavidoNew Drug Application2021-03-05
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
cutaneous leishmaniasis—D016773B55.1
leishmaniasisEFO_0005044D007896B55
visceral leishmaniasis—D007898B55.0
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
P: Antiparasitic products, insecticides and repellents
— P01: Antiprotozoals
— P01C: Agents against leishmaniasis and trypanosomiasis
— P01CX: Other agents against leishmaniasis and trypanosomiasis in atc
— P01CX04: Miltefosine
HCPCS
No data
Clinical
Clinical Trials
39 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cutaneous leishmaniasisD016773B55.1—961116
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Visceral leishmaniasisD007898B55.0145——9
LeishmaniasisD007896EFO_0005044B55241—27
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Mucocutaneous leishmaniasisD007897EFO_0007379B55.2—1——23
Chronic urticariaD000080223L50.8—1———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMILTEFOSINE
INNmiltefosine
Description
Miltefosine is a phospholipid that is the hexadecyl monoester of phosphocholine. It has a role as an antineoplastic agent, an antiprotozoal drug, an antifungal agent, an immunomodulator, an anti-inflammatory agent, an apoptosis inducer, a protein kinase inhibitor and an anticoronaviral agent. It is a member of phosphocholines and a phospholipid.
Classification
Small molecule
Drug classphosphoro-derivatives; cytostatic phospholipid derivatives
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CCCCCCCCCCCCCCCCOP(=O)([O-])OCC[N+](C)(C)C
Identifiers
PDB—
CAS-ID58066-85-6
RxCUI1494066
ChEMBL IDCHEMBL125
ChEBI ID75283
PubChem CID3599
DrugBankDB09031
UNII ID53EY29W7EC (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
AKT1
AKT1
Organism
Homo sapiens
Gene name
AKT1
Gene synonyms
PKB, RAC
NCBI Gene ID
207
Protein name
RAC-alpha serine/threonine-protein kinase
Protein synonyms
AKT1m, PKB, PKB alpha, Protein kinase B, Protein kinase B alpha, Proto-oncogene c-Akt, rac protein kinase alpha, RAC-PK-alpha, serine-threonine protein kinase, v-akt murine thymoma viral oncogene homolog 1, v-akt murine thymoma viral oncogene-like protein 1
Uniprot ID
Q9BWB6
Mouse ortholog
Akt1 (11651)
RAC-alpha serine/threonine-protein kinase (P31750)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,349 documents
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Safety
Black-box Warning
Black-box warning for: Impavido
Adverse Events
Top Adverse Reactions
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6,660 adverse events reported
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